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United States Patent |
5,267,968
|
Russo
|
December 7, 1993
|
Retention bolster for percutaneous catheters
Abstract
A retention bolster for a percutaneous catheter is disclosed having a
convexly curved exterior surface which contacts the epidermal surface of a
patient. The retention bolster slides over a catheter until contacting the
skin of the patient at the catheter exit site. When secured in place, the
retention bolster rocks along contacting portions between its convexly
curved surface and the epidermal surface of the patient in response to
movement of the catheter about the exit site, thereby alleviating the
added pressure that would otherwise be applied by this movement. Upon the
release of lateral pressure against the catheter device, the bolster
returns to its original upright position. In a second disclosed
embodiment, a flange is provided which extends from the main body of the
bolster which defines a bore that is also sized for slidably receiving and
supporting the catheter, and which provides for angled attachment of the
catheter relative to its exit site.
Inventors:
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Russo; Ronald D. (8 Candleberry Rd., Barrington, RI 02806)
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Appl. No.:
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911171 |
Filed:
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July 9, 1992 |
Current U.S. Class: |
604/174 |
Intern'l Class: |
A61M 005/32 |
Field of Search: |
604/174,177,178,250
215/355
|
References Cited
U.S. Patent Documents
1696763 | Dec., 1928 | Hare | 604/179.
|
3444861 | May., 1969 | Schulte | 604/175.
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3721229 | Mar., 1973 | Panzer | 604/174.
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4645504 | Feb., 1987 | Byers | 604/174.
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4668225 | May., 1987 | Russo et al. | 604/270.
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Foreign Patent Documents |
2057269 | Apr., 1981 | GB | 604/174.
|
Other References
Wilson-Cook Catalog, p. 67, product description sheet for Russell
Gastrostomy Trays.
Superior Biosystems Inc., product description sheet for Caluso Gastrostomy
Tube and Jejunal Feeding Tube.
Superior Biosystems Inc., product description sheet for PEDI PEG Silicone
Gastrostomy Feeding Tube Kit.
Superior Biosystems Inc., product description sheet for Flow-Thru
Replacement Gastrostomy Tube.
Bard Interventional Products, product description sheet for AEI Silicone
Replacement Gastrostomy.
|
Primary Examiner: Swiatek; Robert P.
Claims
What is claimed is:
1. A retention bolster for retaining a tubular medical device against the
epidermal surface at the exit site of the device from the body of a
patient, said bolster comprising:
a main body having a convexly curved exterior surface portion for
contacting the epidermal surface and an upstanding cylindrical portion
extending therefrom; and
means for securely attaching said main body to the tubular medical device
including a longitudinal bore adapted for slidably receiving the tubular
medical device therethroug, said longitudinal bore extending through said
curved exterior portion and said upstanding cylindrical portion of said
main body; and means for clamping the tubular medical device within said
longitudinal bore; and
wherein said main body is attachable to the tubular medical device with
said convexly curved exterior portion in contact with the epidermal
surface, and wherein said main body is rockable along contacting portions
between said convexly curved exterior portion and the epidermal surface in
response to movement of the tubular medical device about the exit site.
2. The retention bolster of claim 1, wherein:
said convexly curved exterior portion of said main body includes an annular
convex surface having a convexly uniform curvature centered about, and
curving away from said longitudinal bore; and
said main body rocks along contacting portions between said annular convex
surface and the epidermal surface.
3. The retention bolster of claim 2, wherein a curvilinear surface extends
between said longitudinal bore and said annular convex surface.
4. The retention bolster of claim 3, and further comprising:
a resiliently flexible flange attached to said main body; and
a second bore disposed in said flange; and
wherein said flange resiliently flexes to a position aligning said second
bore at an angle relative said longitudinal bore when the tubular medical
device is received in said longitudinal and second bores, said resiliently
flexible flange bending the tubular medical device between said
longitudinal bore of said main body and said second bore of said flange.
5. The retention bolster of claim 1, wherein:
said upstanding cylindrical portion is resiliently flexible; and
said longitudinal bore includes a reduced diameter portion;
said upstanding cylindrical portion resiliently flexing to receive the
tubular medical device through said reduced diameter portion, thereby
causing said reduced diameter portion to clamp the tubular medical device
in said longitudinal bore.
6. The retention bolster of claim 5, and further comprising:
a clamp disposed about said upstanding cylindrical portion;
said clamp being adjustable to clamp across said reduced diameter portion,
thereby causing said reduced diameter portion to clamp the tubular medical
device in said longitudinal bore.
7. The retention bolster of claim 6, wherein:
the tubular medical device is a percutaneous gastrostomy catheter; and
wherein said retention bolster cooperates with the percutaneous gastrostomy
catheter to maintain said convexly curved exterior portion of said main
body against the epidermal surface.
8. A retention bolster for retaining a catheter against the epidermal
surface at the exit site of the catheter from the body of a patient, said
bolster comprising:
a main body having a convexly curved exterior portion for contacting the
epidermal surface;
a first bore adapted for slidably receiving the catheter therethrough, said
first bore extending through said main body and said convexly curved
exterior portion;
a flange attached to said main body; and
a second bore extending through said flange and adapted for slidably
receiving the catheter therethrough; and
wherein the catheter is slidably receivable through said first and second
bores, the catheter bending between said first and second bores, and
wherein said main body is attachable to the catheter with said convexly
curved exterior portion in contact with the epidermal surface, and wherein
said main body is rockable along contacting portions between said curved
exterior portion and the epidermal surface in response to movement of the
catheter about the exit site.
9. The retention bolster of claim 8, wherein:
said flange is resiliently flexible between a first unrestrained position
with said second bore aligned substantially parallel with said first bore
and a second restrained position with said second bore aligned
substantially perpendicular relative said first bore; and
said flange resiliently flexes to its second restrained position when the
catheter is received through said first and second bores thereby
maintaining an approximate right angle bend in the catheter between said
first and second bores.
10. The retention bolster of claim 9, wherein:
said curved exterior portion of said main body includes an annular convex
surface having a convexly uniform curvature centered about, and curving
away from said first bore; and
said main body rocks along contacting portions between said annular convex
surface and the epidermal surface.
11. The retention bolster of claim 10, wherein a curvilinear surface
extends between said first bore and said annular convex surface.
12. The retention bolster of claim 8, wherein:
said second bore includes a reduced diameter portion; and
said flange resiliently flexes to receive the catheter through said reduced
diameter portion, thereby causing said reduced diameter portion to clamp
the catheter in said second bore.
13. The retention bolster of claim 12, and further comprising:
a clamp disposed about said second bore; and
wherein said clamp is adjustable to clamp across said reduced diameter
portion, thereby causing said reduced diameter portion to clamp the
catheter in said second bore.
14. The retention bolster of claim 13, wherein:
the catheter is a percutaneous gastrostomy catheter;
wherein the retention bolster cooperates with the percutaneous gastrostomy
catheter to maintain said convexly curved exterior portion of said main
body adjacent the epidermal surface.
Description
BACKGROUND OF THE INVENTION
This invention relates generally to medical devices and, more particularly,
to a retention bolster for adjustably supporting a tubular medical device
adjacent an epidermal surface.
Typically, a retention bolster is positioned at the exit site of a catheter
to hold the catheter securely against the patient's body. The bolster is
locked in place to maintain support of the catheter and prevent bending or
crimping of the catheter at the exit site. So positioned, bolsters apply
continual, direct pressure to the skin at the exit site of the catheter
from the patient's body, sometimes having the effect of inhibiting the
healing of the skin at the exit site of the catheter and possibly causing
necrosis due to the applied pressure.
Bolsters for supporting tubular medical devices, such as catheters, outside
the body have generally focused on maintaining the secure anchoring of the
device to the patient. To provide lateral support, bolsters have employed
flanges, cross-bars, or discs for contacting the epidermal surface. Prior
attempts at minimizing the continual, direct pressure applied by these
supports have included the placement of pads or webs underneath the
cross-bars, for example, of the bolster. Pads and webs, however, have
actually tended to increase the localized pressure at the exit site,
especially when the catheter, either accidentially or intentionally, is
moved thereabout. Further, as percutaneous catheter placement techniques
have become increasingly common, catheters have been increasingly used for
longer periods of time. As such, infections of the skin at the catheter
exit site have become increasingly common as well.
One particular application magnifying the deficiencies of existing bolsters
involves the use of percutaneous gastrostomy catheters (PEG tubes) to
provide long term access into the stomach. A PEG tube is maintained at its
stoma exit site by a retention bolster for several months while it is used
to provide access into the stomach. Existing bolsters, however, which
remain inflexibly clamped to maintain the catheter in position during use,
do not accommodate the unavoidable movements of the catheter during this
long period of time. As the catheter is moved about, either accidentally
or as it is handled by attending medical personnel, additional pressure is
often applied causing the bolster to dig into the skin surface and
resulting in pressure sores and maceration of the stoma site. As a result
of these deficiencies, existing bolsters have often been the source of
irritation and infections of the skin.
A need, therefore, exists for an improved retention bolster for use
adjacent an epidermal surface to support a tubular medical device. Such a
bolster should securely hold a catheter in place while exerting minimal
amounts of pressure at the catheter exit site, and preferably would permit
movement of the catheter about the stoma exit site without causing or
aggravating injury thereat.
SUMMARY OF THE INVENTION
The present invention provides a new retention bolster which securely and
safely supports a percutaneous catheter, or similar device, against an
epidermal surface, and allows for movement of the catheter about its exit
site without causing or aggravating injury to the patient. The retention
bolster includes means for securely attaching to the catheter, and a
convexly curved surface for contacting the epidermal surface of the
patient. The bolster attaches to the catheter with the convexly curved
surface contacting the epidermal surface of the patient, and rocks along
contacting portions between the convexly curved surface and the epidermal
surface in response to movement of the tubular medical device about its
exit site. In this way, a rocking movement about the stoma exit site is
permitted without causing or aggravating injury thereat. Upon the release
of lateral pressure against the catheter device, the bolster returns to
its original upright position. In a second disclosed embodiment, a
flexible flange is provided which includes means for receiving and
securely attaching the catheter at a right angle relative to the exit
site.
One object of the present invention is to provide an improved retention
bolster for use adjacent an epidermal surface to support a tubular medical
device.
Another object of the present invention is to provide a retention bolster
which securely holds a catheter in place while exerting minimal amounts of
pressure at the catheter exit site.
Still another object of the present invention is to provide an adjustable
retention bolster which minimizes the amount of applied pressure at the
stoma site, and accommodatingly adjusts the application of pressure as the
retained catheter is moved thereabout.
It is a further object of the present invention to provide a retention
bolster which applies minimal contact to the skin, thereby allowing for
aeration of the stoma site to promote healing.
A further object of the present invention is to provide a rockably
adjustable retention bolster which permits both rotation of the catheter
and rocking of the catheter in any direction.
Still yet another object of the present invention is to provide a rockably
adjustable retention bolster which is self-centering so as to return the
catheter to its original position after being flexed therefrom.
Another object of the present invention is to provide a retention bolster
which holds a catheter at a right angle relative to the epidermal surface.
Still another object of the present invention is to provide a retention
bolster which is inexpensive to manufacture and adapted to fit various
sizes of catheters and other tubular medical devices.
These and other related objects and advantages of the present invention
will become apparent from the following drawings and written description.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a perspective view of a rockably adjustable retention bolster
according to one embodiment of the present invention.
FIG. 2 is a top plan view of the rockably adjustable retention bolster of
FIG. 1.
FIG. 3 is a side cross-sectional view taken along lines 3--3 of the
rockably adjustable retention bolster of FIG. 2.
FIG. 4 is a partial side cross-sectional view of the rockably adjustable
retention bolster of FIG. 1 releasably attached to a percutaneous
gastrostomy catheter and cooperating therewith to maintain pressure at a
stoma exit site.
FIG. 5 is a side elevational view of the rockably adjustable retention
bolster of FIG. 4 depicted in an adjusted position in response to movement
of the percutaneous gastrostomy catheter.
FIG. 6 is a perspective view of a rockably adjustable retention bolster
according to another embodiment of the present invention shown in its
free, unrestrained position.
FIG. 7 is a partial side cross-sectional view of the rockably adjustable
retention bolster of FIG. 6 shown in its restrained position bending a
catheter between the bolster's main body and a flange extending therefrom.
DESCRIPTION OF THE PREFERRED EMBODIMENT
For the purposes of promoting an understanding of the principles of the
invention, reference will now be made to the embodiments illustrated in
the drawings and specific language will be used to describe the same. It
will nevertheless be understood that no limitation of the scope of the
invention is thereby intended, such alterations and further modifications
in the illustrated device, and such further applications of the principles
of the invention as illustrated therein being contemplated as would
normally occur to one skilled in the art to which the invention relates.
Referring now to FIGS. 1-3, a retention bolster 10 is shown including an
upstanding cylindrical portion 12 and a convexly curved exterior portion
14. Cylindrical portion 12 defines a longitudinal bore 16 extending
therethrough and through curved exterior portion 14, wherein bore 16 is
sized for slidably receiving and supporting a tubular medical device, such
as a catheter, therein. Curved exterior portion 14 includes annular convex
surface 18 which has a convexly uniform curvature centered about, and
curving away from bore 16 for contacting an epidermal surface. Conversely,
the opposing side to annular convex surface 18 forms a cooperating concave
surface 24, wherein the general configuration of a bowl is assumed.
Extending between longitudinal bore 16 and annular convex surface 18 is
curvilinear surface 20 which provides a smooth transition therebetween. As
such, annular convex surface 18 and curvilinear surface 20 of convexly
curved exterior portion 14 provide a smooth curved surface which securely
holds a catheter to the skin without digging into or otherwise irritating
or damaging the epidermal surface.
In the preferred embodiment, retention bolster 10 is of a one-piece molded
plastic construction. Preferably, retention bolster 10 is constructed of
clear medical grade silicon or synthetic rubber, such as Monsanto
SANTOPRENE.RTM. or Shell Chemical KRATON.RTM.. In either material, a
hardness of 50 Durometer on a Shore A scale is desired for providing both
strength and resiliency. As such, retention bolster 10 is resiliently
deformable to provide a mechanism by which retention bolster 10 releasably
attaches to a catheter. For example, bore 16 may be sized smaller in
diameter than the catheter for receipt therein so that retention bolster
10 resiliently flexes to receive the catheter through the bore, thereby
clamping the catheter in the bore. In the preferred embodiment, bore 16 of
cylindrical portion 12 includes a reduced diameter portion 22. Cylindrical
portion 12 resiliently flexes in the vicinity of reduced diameter portion
22 to receive the catheter, thereby causing the reduced diameter portion
to clamp the catheter in bore 16.
For enhanced clamping and sealing of the catheter in bore 16, retention
bolster 10 also is adapted for receiving a clamping element about
cylindrical portion 12. Retention bolster 10 includes a peripheral
undercut 24 in curved exterior portion 14 to allow clearance for receiving
an adjustable clamping element. Cylindrical portion 12 also includes an
annular flange 26, which acts to retain a clamping element in place, once
received.
Referring now to FIG. 4, retention bolster 10 is shown cooperating with a
percutaneous gastrostomy catheter 28 having an expanded distal tip 30 for
contacting stomach wall or lining 32 of stomach 33. Catheter 28 is
maintained clamped across epidermal layer 34 by the compressive action
between retention bolster 10 and expanded distal tip 30. As such, expanded
distal tip 30 exerts a uniform pressure on stomach wall 32 to maintain a
seal therebetween and ensure rapid healing. Similarly, retention bolster
10 exerts an equal and opposite pressure at stoma exit site 36 necessary
to maintain the compressive action.
As shown in FIG. 4, retention bolster 10 includes an adjustable clamp 38
about cylindrical portion 12. Clamp 38 adjusts to tighten about
cylindrical portion 12 to both clamp and seal catheter 28 within bore 16.
As such, retention bolster 10 is held in place contacting the epidermal
surface 40. In the orientation shown in FIG. 4, catheter 28 is in its
centered position with curvilinear surface 20 of curved exterior portion
14 minimally contacting the epidermal surface. As such, stoma exit site 36
is aerated for rapid healing of stoma tract 42. Further, because of the
minimal contact area and pressure, catheter 28 is able to be rotated 360
degrees within stoma tract 42 without damaging the epidermal surface.
Referring also to FIG. 5, catheter 28 is shown rocked about the stoma exit
site along convex surface 18 and epidermal surface 40 in response to
movement of the catheter. As an external force is applied to the catheter,
such as by positioning the catheter to introduce nutritional liquids into
the stomach via the catheter, retention bolster 10 rocks to reduce the
pressure on epidermal surface 40 and to move its point of application on
the epidermal surface. Because the center of the compressive action
between the retention bolster and the expanded tip is shifted away from
the exit site, an overturning moment is created which acts to center the
catheter once the external force is removed. As such, retention bolster 10
is self-centering. Further, by being self-centering in returning catheter
28 to the orientation shown in FIG. 4, retention bolster 10 acts to
minimize inward migration of the expanded distal tip 30 into the stomach
wall 32.
In many applications it is desirous to maintain the catheter at an angle
relative the exit site of the patient to prevent the catheter from damage
as the patient moves about, such as by rolling over or sitting up.
Referring now to FIGS. 6 and 7, an alternate embodiment of a retention
bolster 100 is shown including convexly curved exterior portion 114.
Curved exterior portion 114 defines a first bore 116 extending
therethrough and through curved exterior portion 114, wherein bore 116 is
sized for slidably receiving and supporting a tubular medical device, such
as a catheter, therein. Curved exterior portion 114 includes an annular
convex surface 118 which has a convexly uniform curvature centered about,
and curving away from bore 116 for contacting an epidermal surface and a
smooth curvilinear surface 120 extending between surface 118 and bore 116.
Unlike retention bolster 10, retention bolster 100 also includes an
outwardly extending flange 112 which defines an additional bore 113 that
is also sized for slidably receiving and supporting a tubular medical
device, and which provides for angled attachment of a catheter relative to
its exit site.
Bore 113 within flange 112 includes a reduced diameter portion 122. Flange
112 resiliently flexes to receive a catheter, thereby causing reduced
diameter portion 122 to clamp a catheter within bore 113. For enhanced
clamping of the catheter within bore 113, flange 112 also is adapted for
receiving a clamping element. Flange 112 includes annular flanges 124 and
126 which maintain a clamping element in place once received. As shown in
FIG. 6, retention bolster 100 is in its free unrestrained position with
bore 113 aligned substantially parallel with bore 116. Because retention
bolster 100 is resiliently deformable, it can assume a restrained position
as shown in FIG. 7. Referring now also to FIG. 7, retention bolster 100 is
shown with a catheter 128 received through bores 113 and 116, wherein the
catheter is bent at a right angle by the force exerted when flange 112 is
resiliently flexed from its free, unrestrained position. As such,
retention bolster 100 maintains the existing portion of catheter 128
substantially parallel with the epidermal surface. Depending upon the
position at which flange 112 is secured to catheter 128 and the
interacting forces therebetween, catheter 128 may also be bent to extend
within a range of desired angles.
In the preferred embodiment, retention bolster 100 also is of a one-piece
molded plastic construction. As previously discussed, retention bolster 10
is preferably constructed of clear medical grade silicon or synthetic
rubber, such as Monsanto SANTOPRENE.RTM. or Shell Chemical KRATON.RTM.. In
either material, a hardness of 50 Durometer on a Shore A scale is desired
for providing both strength and resiliency. As such, retention bolster 100
is resiliently deformable to provide a mechanism by which retention
bolster 100 releasably attaches to a catheter.
While the invention has been illustrated and described in detail in the
drawings and foregoing description, the same is to be considered as
illustrative and not restrictive in character, it being understood that
only the preferred embodiment has been shown and described and that all
changes and modifications that come within the spirit of the invention are
desired to be protected.
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